By Stuart McCully, VP, inVentiv Health Clinical
The recent approval by Britain’s National Health Service (NHS) for the use of electronic informed consent in a clinical trial is a pivotal moment in the global expansion of a technology that benefits both patients and sponsors of clinical research.
Approval for the use of electronic informed consent from the California-based company, Mytrus, was granted by the Health Research Authority (HRA), a division of Britain’s NHS, established to promote and protect the interests of patients participating in research. HRA oversees research ethics committees in England, as well as innovation in research, and the agency is interested in how eConsent technology impacts both trial efficiency and the ethical treatment of patients.
This is the first time eConsent has been approved in Britain. If the electronic enrollment process in England mirrors previous, positive experiences with eConsent, then we expect to see the use in British trials expand while regulatory authorities in other countries follow suit, reassured by the approval from a rigorous regulatory agency. London is home to the European Union’s European Medicines Agency (EMA), which will undoubtedly be following trial progress.
With this approval, Mytrus becomes the first company offering eConsent technology that has been approved by regulators on both sides of the Atlantic. The U.S. Food and Drug Administration approved its use in a clinical trial back in 2011. Now, four years later, eConsent adoption is reaching a tipping point in the United States. Other technologies are now in the market, and the FDA has issued draft guidance on eConsent that is stirring adoption rates. Influential industry groups, including TransCelerate and the Clinical Trials Transformation Initiative, are working to develop best practices and standards to govern the use of eConsent.
The company is now paving the way for the globalization of eConsent, building on use in more than 30 studies and approvals from more than 50 institutional review boards and ethics committees including Brazil’s Comissão Nacional de Ética em Pesquisa (CONEP), Hungary’s National Ethics Committee for Clinical Pharmacology (KFEB), and Institutional Review Boards in Canada.
India, too, is reviewing the use of eConsent through the Central Drugs Standard Control Organization (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices similar in function to the EMA, FDA, and PMDA in Japan. Indian regulators see informed eConsent as better for patients and a potentially valuable tool for reducing fraud. Issues with literacy have raised questions in the past about whether Indian clinical trial participants fully understood what they were consenting to do. E-consent not only enhances patient comprehension, but also helps investigational sites and trial sponsors demonstrate that they’ve done their best to provide patients with state-of-the-art learning tools.
Such international approval is essential to the continued spread of eConsent, which follows in the path of Electronic Data Capture (EDC) and Electronic Trial Master File (eTMF) technologies that were new at one time but now are commonplace across the biopharmaceutical industry. To achieve broad, industry adoption, technologies must evolve to meet global requirements and eConsent is on its way to becoming an accepted standard.
The relatively rapid approval in so many countries reflects a desire on the part of regulators and ethics organizations to enhance the ethical treatment of trial volunteers and patients. Technology puts the needs of patients at the center of the clinical trial consent process by replacing the use of paper documents with technology that better explains study risks, benefits, and alternatives, as well as information on what to expect in a trial. With more information that is better understood, patients can make more informed choices that may help them stay in trial.
For the upcoming trial in England, an electronic tablet will give potential participants a trial overview that includes simple, entertaining videos to reinforce key information. People read the informed consent document, answer questions to assess understanding, and are prompted to review information they don’t adequately understand. Research site staff can track patient metrics to better understand where patients need counseling and dedicate time for each potential study participant to discuss the study with site staff before agreeing to sign consent.
The eConsent pilot, which began enrolling patients last month, is being run in tandem with traditional paper consent so results can be compared. Previous studies have shown that patients are much more likely to correctly answer questions presented in the consent process if the information has been presented electronically rather than on paper.
Beyond the clear benefit to patients, eConsent moves sponsors into the 21st century in the collection and management of electronic signatures, and offers efficiencies for drug companies seeking to manage soaring development costs. The technology provides functions that improve site performance, expedite study start times, and enhance regulatory compliance. Insights gained through the use of the technology help improve the management of relationships with CROs and trial sites and give sponsors detailed data to support interaction with regulatory authorities.
We expect eConsent will deliver more and more cost savings to pharmaceutical companies. Conservative estimates place the cost of traditional enrollment at $500 per patient, but there also are costs associated with implementing new technology. Over time, however, and similar to the trajectory of other technologies, the cost of using electronic consent will decline with increased use. Meanwhile, the additional benefits of real-time access to more patient information, reduced regulatory risks, and analytic metrics not previously available will bring immediate value to trial sponsors. Britain’s approval of eConsent may be just the boost needed to bring about even faster global adoption – good news for clinical trial sponsors, investigative sites, regulators, and, above all, patients participating in essential scientific research.